NCT02851147

Brief Summary

The purpose of the evaluation is to confirm operability and usability of the SL-D301 Slit Lamp and the DC-4 digital camera attachment by conducting a usability evaluation and subsequently submitting a questionnaire and hold an interview with the operator. Of special interest for the study is to confirm whether the illumination level of SL-D301 is enough to perform an eye exam since the maximum illumination level on the SL-D301 is lower than other existing Topcon digital ready slit lamps due to regulations that limit the maximum light intensity on the human eye. The SL-D301 will be compared against the predicate device SL-3G.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

Same day

First QC Date

July 25, 2016

Last Update Submit

June 6, 2022

Conditions

Ocular Images

Outcome Measures

Primary Outcomes (1)

  • Image Comparison of DC-4 to the SL-D301

    1 Hour

Study Arms (1)

Any Willing and Able Person for Ocular Imaging

Any Willing and Able Person for Ocular Imaging

Device: SL-D301Device: DC-4Device: SL-3G

Interventions

SL-D301DEVICE

Slit Lamp

Any Willing and Able Person for Ocular Imaging
DC-4DEVICE

Digital Camera Attachment

Any Willing and Able Person for Ocular Imaging
SL-3GDEVICE

Slit Lamp

Any Willing and Able Person for Ocular Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subject population will consist of a maximum number of 30 volunteer subjects consenting to undergo a slit lamp eye exam and to have digital images of their eyes obtained with the DC-4 and the SL-D301.

You may qualify if:

  • Any Willing Subject

You may not qualify if:

  • Subjects unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glassman Eye Associates

Teaneck, New Jersey, 07766, United States

Location

Study Officials

  • Ricardo Almiron

    Topcon Corporation

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 1, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

US(1)